Feasibility Study

Brazil and Dominican Republic

Clinical Trial ID:
NCT 06152341

Objective

This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of the Katana Thrombectomy System in subjects with acute pulmonary embolism (PE).

Principal Investigator

Rogerio Souza, MD PhD

Professor, Pulmonary Division, Heart Institute (INCOR), University of Sao Paulo, Brazil

Study Design

Prospective, single-arm, interventional, multicenter study

30 patients at up to 4 sites

Follow-up at 48 hours and 30 days post-thrombectomy procedure

Primary Endpoints

Effectiveness: Change in RV/LV ratio from baseline to 48 hours as assessed by CTA

Safety: Composite measure of major adverse events within 48 hours post-procedure

Key Inclusion Criteria

  • Clinical signs and symptoms consistent with acute PE for < 14 days
  • CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery as determined by the investigator)
  • RV/LV ratio > 0.9
  • Systolic BP ≥90 mmHg without the need for vasopressors
  • Stable heart rate (HR) < 130 BPM prior to procedure
  • Patient is > 18 and < 90 years old

Abbreviations: PE, pulmonary embolism; RV, right ventricular, LV, left ventricular; sPESI, simplified Pulmonary Embolism Severity Index

Status

Currently enrolling